Best way to train general practitioners to identify and recruit eligible patients into the trial

Most effective method of presenting the trial (and randomization) to patients

Barriers to recruitment and how to overcome those barriers

Best tools to use to measure anxiety/depression that may be caused by unnecessary chest-x-rays or no chest x-rays

Best measures of resource use to facilitate health economic analysis of the cost-effectiveness of 'extra-NICE'

Stage at diagnosis, performance status, and the proportion of patients receiving radical treatments in those diagnosed with lung cancer

False-positive and false-negative rates for chest x-rays

Original Secondary Outcome Measures ICMJE

Same as current

Current Other Outcome Measures ICMJE

Not Provided

Original Other Outcome Measures ICMJE

Not Provided

Descriptive Information

Brief Title ICMJE

Standard Medical Care or Urgent Chest X-ray in Diagnosing Lung Cancer in Smokers With Chest Symptoms Who Are Older Than 60 Years

Official Title ICMJE

A Pilot Clinical Trial Looking at the Effect on Lung Cancer Diagnosis of Giving a CXR to Smokers Aged Over 60 With Chest Symptoms

Brief Summary

RATIONALE: Diagnostic procedures, such as an urgent chest x-ray, may help in planning cancer treatment. It is not yet known whether standard medical care is more effective than an urgent x-ray in diagnosing lung cancer in smokers with chest symptoms who are older than 60 years.

PURPOSE: This randomized clinical trial is studying standard medical care to see how well it works compared with an urgent chest x-ray in diagnosing lung cancer in smokers with chest symptoms who are older than 60 years.

Detailed Description

OBJECTIVES:

Primary

To determine the prevalence of extra-NICE symptoms in patients consulting in UK general practice.

To determine the proportion of patients who agree to participate in the trial.

To determine the proportion of patients who are diagnosed with lung cancer and the best sources of routine data for capturing lung cancers.

Secondary

To determine the best way to train general practitioners to identify and recruit eligible patients into the trial.

To determine the most effective method of presenting the trial (and randomization) to patients.

To determine the barriers to recruitment and how to overcome those barriers.

To determine the best tools to use to measure anxiety/depression that may be caused by unnecessary chest-x-rays or no chest x-rays.

To determine the best measures of resource use to facilitate health economic analysis of the cost-effectiveness of 'extra-NICE'.

To determine the stage at diagnosis, performance status, and the proportion of patients receiving radical treatments in those diagnosed with lung cancer.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

Arm A: Patients are managed as per the National Institute for Health and Clinical Excellence (NICE) guidelines.

Arm B: Patients are referred for an urgent chest x-ray according to extra-NICE guidelines.

General practitioners from South East Wales are surveyed to assess their level of interest in the proposed full trial. For the feasibility study, 20 South East Wales general practices and 6 South Yorkshire general practices are selected. General practitioners are trained to recruit all patients who fulfill the extra-NICE criteria as well as those who do not.

Patients complete questionnaires (HADS, EQ-5D, and ICECAP[O]) at baseline and at 2 months to measure quality of life and health economic analysis of the cost-effectiveness of extra-NICE guidelines.

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Unknown status

Estimated Enrollment ICMJE

386

Completion Date

Not Provided

Estimated Primary Completion Date

June 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

DISEASE CHARACTERISTICS:

Patients over 60 seeing a participating General Practitioner

Currently smokes 10 or more pack years, meeting at least one of the following criteria:

New or altered cough of any duration reported to primary care

Increased breathlessness or wheezing (with or without purulent sputum)

Do not qualify for an urgent referral for a chest x-ray under the National Institute for Health and Clinical Excellence (NICE) guidelines (i.e., hemoptysis or unexplained or persistent [lasting > 3 weeks] signs or symptoms), including having any of the following:

Cough

Chest/shoulder pain

Dyspnea

Weight loss

Chest signs

Hoarseness

Finger clubbing

Features suggestive of metastasis from a lung cancer (e.g., in the brain, bone, liver, or skin)

Cervical/supraclavicular lymphadenopathy

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

No chest x-ray within in past 3 months

No need for a chest x-ray within the next 3 weeks for reasons other than those listed under Disease Characteristics

Sex/Gender

Sexes Eligible for Study:

All

Ages

60 Years and older (Adult, Senior)

Accepts Healthy Volunteers

No

Contacts ICMJE

Contact information is only displayed when the study is recruiting subjects